This invention relates to a vessel suitable for use in testing the sterility of drugs, medical devices and the like. Such vessels are used, for example, in testing for the presence of microbiological contamination in drugs, bandages, catheters, syringes, sutures, gloves, and other medical equipment or components.
The object of sterility testing is to determine whether drugs and medical devices which are required to be sterile are in fact free of living organisms. The process entails opening a sealed product to be tested under highly aseptic environmental conditions and then introducing the product into a vessel containing an appropriate sterile culture medium. The vessel is closed and incubated for a specific time (for example, 14 days at 32.degree. C.) and then examined for microbiological growth. Since a single cell can grow and result in a positive test, it is important to minimize the risk of external microbiological contamination, thus insuring that any growth which may occur can be attributed to an organism originally present in the product itself. It is accordingly important to insure that the vessel in which the product is incubated adequately protects the product from external contamination.
Although several types of culture tubes and vessels have been employed for sterility testing, generally these have not been designed specifically for this purpose and have disadvantages in relation to size, shape, ease of handling, susceptibility to external contamination and a tendency, with repeated autoclaving, to break or create a separation between the vessel and its closure.
It is an object of the present invention, therefore, to provide a vessel particularly suitable for use as a sterility testing vessel.
It is a further object of the invention to provide a specific form of closure for a sterility testing vessel which produces an effective sealing of the vessel against external contamination while still allowing venting of the vessel, for example, during autoclaving.
Another object of the invention is to provide a closure for a vessel which incorporates a form of filter structure that will permit venting of the vessel interior for example, during autoclaving while effectively sealing the vessel against external microbiological contamination.
Still a further object of the invention is to provide a sterility testing vessel which is simple to handle, can be easily cleaned and repeatedly used and which can be economically manufactured from readily available materials.